Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005064
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
2000-04-06
Brief Title:
PS-341 in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Chronic Myeloid Leukemia in Blast Phase or Myelodysplastic Syndrome
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of PS-341 in Acute Myeloid Leukemias Myelodysplastic Syndromes and Chronic Myeloid Leukemia in Blast Phase
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase I trial to study the effectiveness of PS-341 in treating patients who have refractory or relapsed acute myeloid leukemia acute lymphoblastic leukemia chronic myeloid leukemia in blast phase or myelodysplastic syndrome PS-341 may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose of PS-341 in patients with refractory or relapsed acute myeloid leukemia acute lymphoblastic leukemia myelodysplastic syndrome or chronic myeloid leukemia in blast phase
II Assess the plasma pharmacology of this drug its ability to inhibit proteasome function and to accelerate apoptosis in circulating blasts in this patient population
III Assess the antileukemic effects of this drug in these patients
OUTLINE This is a dose-escalation study
Patients receive PS-341 IV bolus twice weekly for 4 weeks followed by 2 weeks of rest Treatment continues for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression
Cohorts of 2 patients receive escalating doses of PS-341 until the maximum tolerated dose MTD is determined The MTD is defined as the dose level associated with toxicity probability closest to 02 after 30 patients are treated
I Determine the maximum tolerated dose of PS-341 in patients with refractory or relapsed acute myeloid leukemia acute lymphoblastic leukemia myelodysplastic syndrome or chronic myeloid leukemia in blast phase
II Assess the plasma pharmacology of this drug its ability to inhibit proteasome function and to accelerate apoptosis in circulating blasts in this patient population
III Assess the antileukemic effects of this drug in these patients
OUTLINE This is a dose-escalation study
Patients receive PS-341 IV bolus twice weekly for 4 weeks followed by 2 weeks of rest Treatment continues for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression
Cohorts of 2 patients receive escalating doses of PS-341 until the maximum tolerated dose MTD is determined The MTD is defined as the dose level associated with toxicity probability closest to 02 after 30 patients are treated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000067668 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA062461 |
| DM 99-245 | None | None | None |
| U01CA062461 | NIH | None | None |